Jardiance scores more cardiovascular outcomes data

pharmafile | November 10, 2015 | News story | Manufacturing and Production Boehringer, Boehringer Ingelheim, Eli Lilly, Novo Nordisk, Victoza, cardiovascular outcomes, diabetes, empagliflozin, jardiance, lilly, liraglutide, type 2 diabetes 

A sub-group analysis of data from an outcomes study of Boehringer Ingelheim’s and Lilly’s Jardiance has found the diabetes drug reduces the risk of heart failure outcomes by 39%.

Earlier this year the two companies in the diabetes alliance presented preliminary data from the EMPA-REG OUTCOMES trial, which was the first to find that a blood sugar-lowering drug could reduce the risk of cardiovascular events. The data was described as “a first for the field of diabetes.”

The latest study, a sub-analysis presented at the American Heart Association meeting in Orlando, looked at more than 7,000 patients from 42 countries with type 2 diabetes, who were at high risk of cardiovascular events: heart attacks, stroke, or heart failure, or death from heart disease.

The study assessed the effect of Jardiance (empagliflozin), either 10 mg or 25 mg a day, added to standard care compared with placebo added to standard care. The standard of care was comprised of treatment with glucose-lowering agents and heart drugs (including for blood pressure and cholesterol).

The sub-analysis found Jardiance reduced the risk of the composite secondary endpoint of rates of hospitalisation for heart failure, or death from heart failure, by 39% compared with placebo.

“Cardiovascular disease, including heart failure, is the leading cause of death associated with diabetes,” says Dr Silvio Inzucchi, professor of medicine at the Yale School of Medicine. “People with diabetes are two to three times more likely to develop heart failure than those individuals without diabetes. We need treatments that can help reduce the high rates of heart failure – and the resulting hospitalisations and deaths – in this population.”

“To date, no glucose-lowering medication has been shown to reduce the risk of hospitalisation for heart failure or death from heart failure in a cardiovascular outcomes study,” says Professor Hans-Juergen Woerle, global vice president of medicine at Boehringer Ingelheim. “These results with Jardiance show the importance of continuing to advance research that will help our understanding of how to manage and mitigate the risk of cardiovascular disease in people with type 2 diabetes.”

However Novo Nordisk did not fare so well in a cardiovascular outcomes study, which it also presented at the AHA meeting this week. In trial of 300 people, Novo Nordisk’s diabetes drug Victoza (liraglutide) did not delay death or hospitalisation in people with advanced heart failure.

An independent trial conducted by researchers from the US government-funded Heart Failure Clinical Research Network, without the involvement of Novo Nordisk, looked at patients with advanced heart failure who did not necessarily have type 2 diabetes patients. Researchers had hoped that the medicine’s effect on blood sugar could mitigate some of the metabolic effects of heart failure.

Under pressure to demonstrate cardiovascular benefits to keep with Jardiance, Novo Nordisk is running the LEADER trial, investigating the impact of Victoza on various cardiovascular outcomes. Results are expected by the end of Q1 2016, and will be presented at next year’s American Diabetes Association’s annual meeting.

Lilian Anekwe

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